| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | B7671R522 | 5.2.2 | Rapid | Rapid System Update | LLZ,POK,QAS | System, Image Processing, Radiological,Computer-Assisted Diagnostic Software For System, Image Processing, Radiological,Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer,Radiological Computer-Assisted Triage And Notification Software | 2 | Rapid |
| 2 | B7671R521 | 5.2.2 | Rapid | POK,LLZ,QAS | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer,System, Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer,System, Image Processing, Radiological,Radiological Computer-Assisted Triage And Notification Software | 2 | Rapid | |
| 3 | B7671R520 | 5.2.0 | Rapid | LLZ,POK,QAS | System, Image Processing, Radiological,Computer-Assisted Diagnostic Software For System, Image Processing, Radiological,Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer,Radiological Computer-Assisted Triage And Notification Software | 2 | Rapid | |
| 4 | B7671R512 | 5.1.2 | Rapid | POK,QAS,LLZ | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer,Radiolog Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer,Radiological Computer-Assisted Triage And Notification Software,System, Image Processing, Radiological | 2 | Rapid | |
| 5 | B7671R511 | 5.1.1 | Rapid | POK,QAS,LLZ | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer,Radiolog Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer,Radiological Computer-Assisted Triage And Notification Software,System, Image Processing, Radiological | 2 | Rapid | |
| 6 | B7671R5030 | 5.0.3 | LLZ,QAS | System, Image Processing, Radiological,Radiological Computer-Assisted Triage And System, Image Processing, Radiological,Radiological Computer-Assisted Triage And Notification Software | 2 | Rapid | ||
| 7 | B761RAPID510 | 5.1 | Rapid 5.1 | LLZ,QAS,POK | System, Image Processing, Radiological,Radiological Computer-Assisted Triage And System, Image Processing, Radiological,Radiological Computer-Assisted Triage And Notification Software,Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | 2 | Rapid | |
| 8 | B761RAPID50210 | 5.0.2.1 | Rapid | Rapid | LLZ,QAS | System, Image Processing, Radiological,Radiological Computer-Assisted Triage And System, Image Processing, Radiological,Radiological Computer-Assisted Triage And Notification Software | 2 | RAPID |
| 9 | B761RAPID5020 | 5.0.2 | LLZ,QAS | System, Image Processing, Radiological,Radiological Computer-Assisted Triage And System, Image Processing, Radiological,Radiological Computer-Assisted Triage And Notification Software | 2 | RAPID | ||
| 10 | B761RAPID5010 | 5.0.1 | LLZ,QAS | System, Image Processing, Radiological,Radiological Computer-Assisted Triage And System, Image Processing, Radiological,Radiological Computer-Assisted Triage And Notification Software | 2 | RAPID | ||
| 11 | B761RAPID500 | 5.0 | Rapid | Rapid | LLZ,QAS | System, Image Processing, Radiological,Radiological Computer-Assisted Triage And System, Image Processing, Radiological,Radiological Computer-Assisted Triage And Notification Software | 2 | RAPID |
| 12 | B761RAPID49101 | 4.9.1 | Rapid | Rapid | LLZ | System, Image Processing, Radiological | 2 | RAPID |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00811852030288 | Viz CTP Software | Viz CTP v1.9 (2022-09-04) | Viz CTP | VIZ.AI, INC. | |
| 2 | 00811852030141 | 1.4 | Viz CTP 1.4 | Viz CTP | VIZ.AI, INC. | |
| 3 | 00811852030103 | 1.3 | Viz CTP 1.3 | Viz CTP | VIZ.AI, INC. | |
| 4 | 00811852030066 | 1.2 | Viz CTP 1.2 | Viz CTP | VIZ.AI, INC. | |
| 5 | 00811852030011 | 1.1 | Viz CTP 1.1 | Viz CTP | VIZ.AI, INC. | |
| 6 | 00810035220379 | 5 | A software application to facilitate management, distribution, and/or viewing of A software application to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data, Including functions for viewing, communication, printing, recording/ disc burning and/or image manipulation. | Radmedix AccuVue+ | RADMEDIX, LLC | |
| 7 | 00810007631103 | ZB-3D208 | ZB-3D208 | ANATOMICAL MODEL, RIB, SINGLE | AccuModel® | MEDCAD |
| 8 | 00810007631073 | ACS_GU | ACS_GU | ANATOMICAL MODEL, GUIDE | AccuModel | MEDCAD |
| 9 | 00810007630861 | ZB-3D108 | ZB-3D108 | ANATOMICAL MODEL, FIBULA | AccuModel® | MEDCAD |
| 10 | 00810007630854 | ZB-3D207 | ZB-3D207 | ANATOMICAL MODEL, SKULL AND MANDIBLE (FUSED) | AccuModel® | MEDCAD |
| 11 | 00810007630847 | ZB-3D206 | ZB-3D206 | ANATOMICAL MODEL, SKULL | AccuModel® | MEDCAD |
| 12 | 00810007630830 | ZB-3D204 | ZB-3D204 | ANATOMICAL MODEL, MANDIBLE AND MAXILLA | AccuModel® | MEDCAD |
| 13 | 00810007630823 | ZB-3D203 | ZB-3D203 | ANATOMICAL MODEL, MAXILLA | AccuModel® | MEDCAD |
| 14 | 00810007630816 | ZB-3D202 | ZB-3D202 | ANATOMICAL MODEL, MANDIBLE | AccuModel® | MEDCAD |
| 15 | 00810007630809 | ZB-3D102 | ZB-3D102 | ANATOMICAL MODEL, GRAFT | AccuModel® | MEDCAD |
| 16 | 00810007630793 | ZB-3D101 | ZB-3D101 | ANATOMICAL MODEL, IMPLANT MODEL | AccuModel® | MEDCAD |
| 17 | 00810007630786 | ZB-3D100 | ZB-3D100 | ANATOMICAL MODEL, HOST BONE PERI-DEFECT | AccuModel® | MEDCAD |
| 18 | 00810007630779 | ZB-3D-M | ZB-3D-M | ANATOMICAL MODEL, MISCELLANEOUS | AccuModel® | MEDCAD |
| 19 | 00810007630762 | ZB-K030 | ZB-K030 | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT W/ PLATE DESIGN | AccuPlan® System | MEDCAD |
| 20 | 00810007630755 | ZB-K021 | ZB-K021 | MIDFACE RECONSTRUCTION, SURGICAL GUIDE | AccuPlan® System | MEDCAD |
| 21 | 00810007630748 | ZB-K020-R | ZB-K020-R | MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT - REPORT | AccuPlan® System | MEDCAD |
| 22 | 00810007630731 | ZB-K020 | ZB-K020 | MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT | AccuPlan® System | MEDCAD |
| 23 | 00810007630724 | ZB-K011 | ZB-K011 | MANDIBLE RECONSTRUCTION, SURGICAL GUIDE | AccuPlan® System | MEDCAD |
| 24 | 00810007630717 | ZB-K010-R | ZB-K010-R | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT - REPORT | AccuPlan® System | MEDCAD |
| 25 | 00810007630700 | ZB-K010 | ZB-K010 | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT | AccuPlan® System | MEDCAD |
| 26 | 00810007630694 | ZB-K004 | ZB-K004 | ORTHOGNATHIC, SURGICAL GUIDE | AccuPlan® System | MEDCAD |
| 27 | 00810007630687 | ZB-K003 | ZB-K003 | ORTHOGNATHIC, 3D PRINTED DENTAL MODELS | AccuPlan® System | MEDCAD |
| 28 | 00810007630670 | ZB-K002 | ZB-K002 | ORTHOGNATHIC, FINAL SPLINT | AccuPlan® System | MEDCAD |
| 29 | 00810007630663 | ZB-K001 | ZB-K001 | ORTHOGNATHIC, INTERMEDIATE SPLINT | AccuPlan® System | MEDCAD |
| 30 | 00810007630656 | ZB-K000-R | ZB-K000-R | ORTHOGNATHIC, SURGICAL PLANNING KIT - REPORT | AccuPlan® System | MEDCAD |
| 31 | 00810007630649 | ZB-K000 | ZB-K000 | ORTHOGNATHIC, SURGICAL PLANNING KIT | AccuPlan® System | MEDCAD |
| 32 | 00810007630533 | MC-K000-R | MC-K000-R | ORTHOGNATHIC, SURGICAL PLANNING KIT - REPORT | AccuPlan System | MEDCAD |
| 33 | 00810007630441 | MC-K020-R | MC-K020-R | MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT - REPORT | AccuPlan System | MEDCAD |
| 34 | 00810007630427 | MC-K020 | MC-K020 | MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT | AccuPlan System | MEDCAD |
| 35 | 00810007630373 | MC-K021 | MC-K021 | MIDFACE RECONSTRUCTION, SURGICAL GUIDE | AccuPlan System | MEDCAD |
| 36 | 00810007630366 | MC-K011 | MC-K011 | MANDIBLE RECONSTRUCTION, SURGICAL GUIDE | AccuPlan System | MEDCAD |
| 37 | 00810007630359 | MC-K010-R | MC-K010-R | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT - REPORT | AccuPlan System | MEDCAD |
| 38 | 00810007630342 | MC-K004 | MC-K004 | ORTHOGNATHIC, SURGICAL GUIDE | AccuPlan System | MEDCAD |
| 39 | 00810007630335 | MC-K010 | MC-K010 | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT | AccuPlan System | MEDCAD |
| 40 | 00810007630328 | MC-K003 | MC-K003 | ORTHOGNATHIC, 3D PRINTED DENTAL MODELS | AccuPlan System | MEDCAD |
| 41 | 00810007630311 | MC-K002 | MC-K002 | ORTHOGNATHIC, FINAL SPLINT | AccuPlan System | MEDCAD |
| 42 | 00810007630304 | MC-K001 | MC-K001 | ORTHOGNATHIC, INTERMEDIATE SPLINT | AccuPlan System | MEDCAD |
| 43 | 00810007630298 | MC-K000 | MC-K000 | ORTHOGNATHIC, SURGICAL PLANNING KIT | AccuPlan System | MEDCAD |
| 44 | 00810007630281 | MC-3D207 | MC-3D207 | ANATOMICAL MODEL, SKULL AND MANDIBLE (FUSED) | AccuModel | MEDCAD |
| 45 | 00810007630274 | MC-3D206 | MC-3D206 | ANATOMICAL MODEL, SKULL | AccuModel | MEDCAD |
| 46 | 00810007630267 | MC-3D204 | MC-3D204 | ANATOMICAL MODEL, MANDIBLE AND MAXILLA | AccuModel | MEDCAD |
| 47 | 00810007630250 | MC-3D203 | MC-3D203 | ANATOMICAL MODEL, MAXILLA | AccuModel | MEDCAD |
| 48 | 00810007630243 | MC-3D202 | MC-3D202 | ANATOMICAL MODEL, MANDIBLE | AccuModel | MEDCAD |
| 49 | 00810007630236 | MC-3D109 | MC-3D109 | ANATOMICAL MODEL, GUIDE | AccuModel | MEDCAD |
| 50 | 00810007630229 | MC-3D108 | MC-3D108 | ANATOMICAL MODEL, FIBULA | AccuModel | MEDCAD |